A Dose-Escalating Phase 0 Study to Evaluate the Safety and Local Cutaneous Reactivity of Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD) in Cat-allergic Healthy Volunteers

NCT01292070 EARLY_PHASE1 TERMINATED Results posted

The purpose of this trial is to show that Intradermal Human Fcγ1-Fel d1 fusion protein (GFD) is able to block the skin reaction to cat allergen in cat allergic subjects compared to the skin reaction to cat allergen alone. This research project is also testing the safety and tolerability of this new, experimental treatment, compared to the current treatment of cat allergen alone.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	EARLY_PHASE1
Status	TERMINATED
Enrolment	4
Start date	2011-03
Completion	2011-04

Conditions

• Cat Allergy

Interventions

• Intradermal Human Fcγ1-Fel d1 fusion protein
• Positive Control - standardized cat hair allergenic extract (CAT)
• Positive Control - Histamine Prick
• Negative Control - Intradermal Diluent

Primary outcomes

• Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema — up to 3 hours after the last injection of GFD
  Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.

Countries

Australia